ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER

Esmolol is rapidly metabolized by hydrolysis of the ester linkage, chiefly by the esterases in the cytosol of red blood cells and not by plasma cholinesterases or red cell membrane acetylcholinesterase. Total body clearance in man was found to be about 20 L/kg/hr, which is greater than cardiac output; thus the metabolism of esmolol is not limited by the rate of blood flow to metabolizing tissues such as the liver or affected by hepatic or renal blood flow. Esmolol has a rapid distribution half-l...

Supraventricular Tachycardia In two multicenter, randomized, double-blind, controlled comparisons of esmolol hydrochloride injection with placebo and propranolol, maintenance doses of 50 to 300 mcg/kg/min of esmolol hydrochloride injection were found to be more effective than placebo and about as effective as propranolol, 3 to 6 mg given by bolus injections, in the treatment of supraventricular tachycardia, principally atrial fibrillation and atrial flutter. The majority of these patients developed their arrhythmias postoperatively. About 60 to 70% of the patients treated with esmolol hydrochl...

Most common adverse reactions (incidence >10%) are symptomatic hypotension (hyperhidrosis, dizziness) and asymptomatic hypotension ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 864-879-9994 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another...

Esmolol hydrochloride injection is contraindicated in patients with: Severe sinus bradycardia: May precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [see Warnings and Precautions ( 5.2 )]. Heart block greater than first degree: Second- or third-degree atrioventricular block may precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [se...

• Risk of hypotension, bradycardia, and cardiac failure: Monitor for signs and symptoms of cardiovascular adverse effects. Reduce or discontinue use ( 5.1 , 5.2 , 5.3 , 5.10 )
• Risk of exacerbating reactive airway disease ( 5.5 )
• Diabetes: May mask symptoms of hypoglycemia and alter glucose levels; monitor ( 5.6 )
• Risk of unopposed alpha-agonism and severe hypertension in untreated pheochromocytoma ( 5.9 )
• Risk of myocardial ischemia when abruptly discontinued in patients with coronary ar...

7 DRUG INTERACTIONS Concomitant use of esmolol hydrochloride injection with other drugs that can lower blood pressure, reduce myocardial contractility, or interfere with sinus node function or electrical impulse propagation in the myocardium can exaggerate esmolol hydrochloride injection’s effects on blood pressure, contractility, and impulse propagation. Severe interactions with such drugs can re...